510(k) · Cleared

Cleared

Compumedics Somte System

K021176510(k) TraditionalCleared Jan 21, 2003284-day reviewClass II21 CFR 868.2375

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Compumedics Limited · MNR Ventilatory Effort Recorder

Cleared on Jan 21, 2003 as substantially equivalent to K000068 (Compumedics Neuro Science Pty, Ltd., 2000) and 1 other predicate after a 284-day review. Its family tree reaches back 1 generation to 2000. 95 later devices descend from it.

Decided: Jan 21, 2003
Review: 284 days
Class: Class II
Product code: MNR
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K000068 (2000). 2 ancestors in all. 95 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK000068 Compumedics E-Series Eeg SystemCompumedics Neuro Science Pty, Ltd. · 2000 · Recalled
This deviceK021176 Compumedics Somte SystemCompumedics Limited · 2003
Descendant · cites it directly · 48 of its ownK072201 Compumedics Somte PSG Recording SystemCompumedics Limited · 2008
Descendant · cites it directly · 41 of its ownK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
Descendant · 2 generations on · 40 of its ownK111194 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011
Descendant · 3 generations on · 38 of its ownK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
Descendant · 2 generations on · 27 of its ownK122516 Embletta MPREmbla Systems · 2013 · Recalled

Showing 5 of 95 descendants. See all descendants

Descendants cleared per year

2004high 12 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 95 · See all

K072201Compumedics Somte PSG Recording SystemCompumedics Limited · 2008 · cites it directly48descendants
K073682Embletta GoldEmbla Systems, Inc. · 2008 · cites it directly41descendants
K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011 · 2 generations on40descendants
K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012 · 3 generations on38descendants
K122516Embletta MPREmbla Systems · 2013 · 2 generations on27descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000068	Compumedics E-Series Eeg System	Compumedics Neuro Science Pty, Ltd.	2000	1
0 (this device)	K021176	Compumedics Somte System	Compumedics Limited	2003	—
+1	K072201	Compumedics Somte PSG Recording System	Compumedics Limited	2008	—
+1	K073682	Embletta Gold	Embla Systems, Inc.	2008	1
+2	K111194	Apnea Risk Evaluation System (Ares)	Advanced Brain Monitoring, Inc.	2011	—
+3	K112514	Apnea Risk Evaluation System (Ares)	Advanced Brain Monitoring, Inc.	2012	—
+2	K122516	Embletta MPR	Embla Systems	2013	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	1	0
2008	2	0
2009	2	0
2010	2	0
2011	2	0
2012	3	0
2013	4	0
2014	1	0
2015	3	0
2016	2	0
2017	6	0
2018	3	0
2019	5	0
2020	4	0
2021	3	0
2022	9	0
2023	10	0
2024	8	0
2025	12	0
2026	11	0

FIG. 1 — Lineage of K021176, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MNR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MNR device

#1 K244027 Sansa Hsatscore 18.1 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K000068	Compumedics E-Series Eeg System Summary page 1 …ices Compumedics Limited believes the Compumedics Somte Patient Recording System is substantially equivalent to: The Compumedics Limited E-Series System (K000068) (for the sleep/cardio- respiratory recording component); and the Oxford Instruments Medilog@Excel 3 Holter Management…	Compumedics Neuro Science Pty, Ltd.	2000	1
*	K002544	Medilog Excel 2 - Holter Management System Summary page 1 …imited E-Series System (K000068) (for the sleep/cardio- respiratory recording component); and the Oxford Instruments Medilog@Excel 3 Holter Management System, (K002544) (for the electrocardiograph (ECG) recording component). 3. Description of the Device The Compumedics Somte Patient…	Oxford Instruments	2000	—

Also cleared against K000068: 3 other devices →

What descends from it? (95)

See all 95

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K072201	Compumedics Somte PSG Recording System	Compumedics Limited	2008	48
K073682	Embletta Gold	Embla Systems, Inc.	2008	41
K040194	Compumedics Summit IP	Compumedics USA, Ltd.	2004	13
K052573	Stardust II	Respironics, Inc.	2005	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K072201 (Compumedics Limited, 2008) has gone furthest, with 48 descendants of its own.
3 other devices also cite its predicate K000068.

How does its category compare?

All MNR devices

MNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNR

10in 2025

2007high 14 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNR

165in 2025

2007high 383 (2019) · low 89 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNR

1in 2021

2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNR

43in 2025

2007high 43 (2025) · low 0 (2008)2025

MAUDE reports naming product code MNR, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	124	2	1
2008	14	118	0	0
2009	8	89	1	0
2010	0	—	0	1
2011	9	90	1	1
2012	1	—	0	1
2013	4	161	0	0
2014	2	—	0	1
2015	4	229	0	4
2016	3	281	0	10
2017	4	275	0	4
2018	3	147	0	2
2019	8	383	0	3
2020	5	192	0	5
2021	3	137	1	5
2022	7	266	0	4
2023	6	183	0	13
2024	6	217	0	11
2025	10	165	0	43
2026	5	227	1	—

What is it indicated for?

The SomtC System is a multi-functional ambulatory recording device intended to be used to collect and store signals related to sleep disorders, including respiratory signals, ECG signals and limb movement signals, to aid in the diagnosis of respiratory andor cardiac related sleep disorders.

The SomtC System is not intended for use as life support equipment such as vital signs monitoring in intensive care units.

The SomtC System is only to be used under the direction and supervision of a physician, technologist or clinician. It will not prevent or restore the interruption or loss of any physiological system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021176 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021176: Compumedics Somte System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021176

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026